4th report on the monitoring of patent settlements (period...
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Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111
EUROPEAN COMMISSION Competition DG
4th Report on the Monitoring of Patent Settlements
(period: January-December 2012)
Published on 9 December 2013
1. Introduction
(1) As announced in the Commission's Communication1 concluding the
pharmaceutical sector inquiry on 8 July 2009, it is considered important to
continue monitoring the patent settlements between originator and generic
companies. The main objectives of the monitoring exercise are to better
understand the use of this type of agreement in the EEA and to identify those
settlements that delay generic market entry to the detriment of the European
consumer possibly in violation of European competition law.2 This fourth round
of monitoring is a follow-up to the three monitoring exercises conducted
annually from 2010 to 20123.
(2) Patent settlement agreements, as examined in this context, are commercial
agreements to settle patent-related disputes, e.g. questions of patent
infringement or patent validity. They are concluded in the context of patent
disputes, opposition procedures or litigation where no final adjudication has
been handed down. Although the content of individual settlements will vary
according to the circumstances of the case, the common aim of a settlement is
to end the disagreement.
(3) As in any other area of commercial disagreement, the parties concerned have a
legitimate interest in finding a mutually acceptable compromise. In particular
the parties may prefer to discontinue the dispute or litigation because it is too
1 The full texts of the Commission Communication on the final report (hereinafter: Commission
Communication) as well as the final report as technical annex to the communication are available at
the website of DG Competition:
http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/index.html.
See also Press Release IP/09/1098 and MEMO/09/321.
2 Commission Communication, p. 20.
3 The three reports on the monitoring of patent settlements are available at:
http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/patent_settlements_report1.pdf ,
http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/patent_settlements_report2.pdf and
http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/patent_settlements_report3_en.pdf.
2
costly, time-consuming and/or risky as regards its outcome. Settlements are
thus a generally accepted, legitimate way of ending private disagreements. They
can also save courts and/or competent administrative bodies such as patent
offices' time and effort. Therefore, they can have some positive impact in the
interest of society.
(4) However, as pointed out in the Final Report of the sector inquiry ("Final
Report"), some patent settlements in the pharmaceutical sector may prove to be
problematic from a competition law perspective. Of particular interest are
settlements that may lead to a delay of generic entry in return for a value
transfer (e.g. a payment) by the originator company to the generic company.
Other examples of possibly problematic agreements relate to settlements that
contain restrictions beyond the exclusionary zone of the patent, meaning that
they would reach beyond its geographic scope, its period of protection or its
exclusionary scope. Such agreements would not appear to be directly related to
the IP rights granted by the patents concerned. Furthermore, problematic
agreements include settlement agreements on a patent which the patent holder
knows does not meet the patentability criteria. An example of this is a situation
where the patent was granted following the provision of incorrect, misleading
or incomplete information. Ultimately, it may be the consumer who pays the
price for a delay in market entry resulting from such agreements and therefore
any benefits to society are more than outweighed by the negative effects of the
agreement between potential competitors. In this context, obviously, an
assessment of each individual case would be necessary.
(5) The Competition DG launched the fourth monitoring exercise into patent
settlements in January 2013 covering the time period from 1 January 2012 to 31
December 2012. Formal requests for information were sent to originator
companies and generic companies, which had cooperated with the Commission
in the course of the sector inquiry and/or were reported in the specialised press
as having concluded a patent settlement in the period in question.
(6) This report sets out the results of the fourth monitoring exercise. The first
section recalls the main classifications of patent settlements as set out in detail
in the Final Report. It then provides the overview of the replies submitted by
companies, including an analysis of the main characteristics of the settlements
falling within particular categories. The final section contains some brief
conclusions.
(7) As in the previous monitoring reports the classification of settlements is aimed
at giving an indication on which kinds of settlements may merit further
competition rules scrutiny and their relative importance. It needs to be
underlined that any concrete case will have to be examined under its own
individual circumstances and merits.
3
2. Classification of the agreements
(8) In its Final Report, the Commission proposed a categorisation of patent
settlement agreements which will also be used for the purpose of this report. In
this context it has to be underlined that this report is written from a competition
law perspective which does not put into question the patent system or its
procedure or criteria for granting exclusive rights. In a nutshell it is based on
two main criteria, firstly, whether the agreement foresees a limitation on the
generic company's ability to market its own medicine and secondly, whether it
foresees a value transfer from the originator to the generic company.4
(9) For the purpose of this analysis, a generic company's ability to enter the market
can be limited in several ways. The most straightforward limitation occurs
when the settlement agreement contains a clause explicitly stating that the
generic company will refrain from challenging the validity of the originator
company's patent(s) ("non-challenge clause") and/or refrains from entering the
market until the patent(s) have expired ("non-compete clause"). A licence
granted by the originator company allowing market presence of the generic
company is also categorised as limiting generic entry, because the generic
company cannot enter the market with its own product or it cannot set the
conditions for the commercialisation of its product freely.5 Accordingly, the
generic company's entry is at least partly controlled by the originator company
through the terms of the licence agreement. Note though, that an exception
applies in case of royalty free licenses that allow generic companies to
immediately launch their own product without any further constraints, i.e.
concerning quantities, composition, pricing or other marketing conditions of
their product. Hence, such license agreements are not viewed as limiting
generic entry.
(10) The same logic as referred to in the first part of paragraph (9) applies to patent
settlement agreements in which the parties agree that the generic company will
be a distributor of the originator product concerned or if the generic company
will source its supplies of the active pharmaceutical ingredient (API) from the
originator company.
(11) Furthermore, agreements providing for an early entry of a generic medicine will
be seen as limiting generic entry where entry is not immediate. It should be
noted that the list of potential limitations is not exhaustive.
(12) Also, the value transfer from the originator company to the generic company
can take different forms. The most clear-cut form of value transfer is a direct
monetary transfer (e.g. payment of a lump sum) from the originator company to
4 For the purpose of this report, it was not verified whether any settlement relates to patents where the
patent holder knows that his patent does not meet the patentability criteria or whether it contains
restrictions exceeding the exclusionary zone of the patent invoked.
5 This categorisation is done for competition law purposes only. It does not prejudice the right of patent
owners to assign, or transfer by succession, the patent and to conclude licensing contracts as declared
in Art. 28 (2) TRIPS.
4
the generic company. According to the settlement terms, such a monetary
transfer can, for example, have the purpose of purchasing an asset (e.g. the
generic company's stock of own products), but it can also have the purpose –
explicitly or implicitly – of paying the generic company for agreeing to delay
the product launch and/or for discontinuing the patent challenge, even in
situations where stock is bought at market price. It is considered that originator
companies are able to afford such payments as the settlement allows the
company to continue reaping the benefits of its well-selling medicine. Other
types of value transfer include distribution agreements or a "side-deal" in which
the originator company grants a commercial benefit to the generic company, for
example by allowing it to enter the market before patent expiry in another
geographical area or by allowing market entry with another product marketed
by the originator company. A value transfer could furthermore consist in
granting a licence to the generic company enabling it to enter the market.
Similarly, a non-assert clause, whereby - even without a license - the originator
binds itself not to invoke the patent against the generic company, thereby
allowing the generic medicine to come onto the market, may technically be
perceived as constituting a value transfer. In these cases, the generic gained
marketable value as a result of the value transfer. However, an agreement which
includes no other limitative provision than determining the date of the generic
entry with the originator's undertaking not to challenge such entry (a "pure early
entry") is not likely to attract the highest degree of antitrust scrutiny. Again the
list of possible value transfers is not exhaustive.
(13) For any of the value transfers observed in this monitoring exercise, the
Commission only investigated whether such a transfer was agreed upon,
without verifying the (net) amount of the transfer or any possible justifications
for it. There is no presumption of violation of competition rules. A case by case
analysis would be required. For instance, in some instances, an early entry may
be pro-competitive when compared to the parties' anticipated outcome of the
litigation. In other instances, the conditions attached to the early entry (through
a licence or a distribution agreement) may cancel out any positive effect on
competition.
(14) In line with the above, agreements that do not restrict the generic company's
ability to market its own product are categorised as A-type, while those limiting
generic entry are categorised as B-type. Agreements limiting generic entry are
further categorised in two groups: (i) B.I settlements, which comprise those
settlements where no value transfer from the originator to the generic company
took place; and (ii) B.II settlements which foresee a value transfer from the
originator to the generic company.
(15) Typically, category A settlements should be unproblematic from a competition
law perspective, as they allow immediate market entry by the generic company
with its own product (unilateral conduct of the originator company that might
have caused generic delay would remain subject to competition law scrutiny).
(16) The same applies to category B.I settlements. Nonetheless, some settlement
agreements in this category may attract competition law scrutiny. This may be
the case for settlements concluded outside the exclusionary zone of the patent
and/or settlement agreements on a patent for which the patent holder knows that
5
it does not meet the patentability criteria, e.g. where the patent was granted
following the provision of incorrect, misleading or incomplete information.
(17) By contrast category B.II settlements are likely to attract the highest degree of
antitrust scrutiny since they limit access to the market and contain a value
transfer from the originator to the generic. Nonetheless, this is not to suggest
that agreements falling into this category would always be incompatible with
EU competition law. This needs to be assessed on the basis of the
circumstances of each individual case.
(18) The table below provides an overview of the main categories as used by the
Commission in the sector inquiry and for the purpose of the monitoring
exercise.
Limitation on generic entry
No Yes
Value transfer
from the
originator
company to the
generic company
No
Category A
Category B.I.
Yes Category B.II.
Source: European Commission, 4th Patent Settlement Monitoring Exercise
6
3. The Monitoring Exercise 2012
(19) The monitoring exercise was launched in January 2013 and covered the period
from 1 January 2012 to 31 December 2012. In total 53 originator and 66 generic
companies were asked to submit to the Commission a copy of all patent
settlement agreements relevant for the EU/EEA markets. These companies were
selected from the originator companies and generic companies that had
cooperated with the Commission in the course of the sector inquiry6 including
the subsequent monitoring exercises and/or were reported in the specialised
press as having concluded a patent settlement in the period in question. Hence it
constitutes a representative sample of the industry. In order to minimise the
administrative burden on the companies, they were asked to submit a copy of
the agreements together with copies of all annexes, related agreements and
amendments concluded between originator and generic companies and only
limited additional background information. The Commission ensured that it
received replies from all relevant operators.
(20) The statistics provided below, which are based on the companies’ replies,
concern only patent settlements in the narrow sense (i.e. settling a patent
dispute, opposition procedure or litigation). Where other agreements were
submitted within the monitoring exercise, they were also analysed with respect
to the question whether they amount to a side deal/related agreement but were
otherwise disregarded.
3.1. Some general statistics of the patent settlements submitted to the
Commission
(21) The development of patent settlements from the beginning of 2000 until the end
of 2012 can be described by consolidating the data obtained in the course of the
sector inquiry and in the course of the previous monitoring exercises with the
information newly acquired during this monitoring exercise.
(22) Figure 1 shows the annual numbers of patent settlements concluded during
2000 – 2012 as well as the numbers of INNs7 covered by the patent settlements
in each year.
6 During the sector inquiry 43 originator companies and 27 generic companies had been selected for in-
depth analysis.
7 An INN is the international non-proprietary name for a pharmaceutical substance.
7
(23) As already pointed out in the Final Report, the number of patent settlement
agreements at the beginning of this period (2000-2002) was comparatively low,
whereas thereafter a significant increase can be observed. The sharp increase in
patent settlements concluded in the last four years may be due to a variety of
reasons, such as the medicines losing patent protection, a general increase in
litigation and disputes leading to a higher number of settlements8, or the greater
readiness of both parties to settle.9 In particular, this year, the new legislation in
Portugal seems to have resulted in more settlements.10
(24) Figure 2 shows the percentages of originator and generic companies addressed
by this monitoring exercise that had concluded patent settlements, as well as the
total numbers of companies having responded to the monitoring exercise.
8 For 2012, it must be noted that new legislation in Portugal, as described in paragraph (27), has entailed
the conclusion of many settlements during 2012. If one withdraws these settlements related to the new
legislation in Portugal ("PT-related"), the total number of settlements for 2012 is 125, slightly above
the level of the previous year.
9 The increase however cannot be explained by the number of companies added in the second
monitoring exercise vis-à-vis the sector inquiry, as the added companies had hardly any effect on the
number of settlements (they amounted in fact to less than 3% of the companies that had concluded a
settlement in the period of the second monitoring exercise).
10 See footnote 8 above.
8
(25) Figure 3 breaks down the number of patent settlements by geographic area
covered by the agreements. Every agreement accounted for in Figure 3 covered
at least one EU Member State.11
Some of the settlements covered more than one
Member State. For the purpose of this figure settlements relating to more than
one Member State are counted as a separate patent settlement for each Member
State (which explains why the sum of the settlements per Member States
exceeds the total number of settlements reported).
11
It is recalled that Croatia joined the EU on 1 July 2013 and has not been listed as a separate Member
State in this report.
9
(26) 11% (20 out of 183) of settlements covered most of or the entire EU in 2012. In
addition, several of these also covered EFTA countries outside the EU, and 2%
(3) were global (not indicated in Figure 3). 3% (5) of settlements concerned
States outside the EU but within the EEA. Figure 3 shows the wide geographic
coverage of settlements in the EU with the number of settlements covering most
of or the entire EU increasing. Smaller and more recent Member States tend to
be covered by fewer patent settlements than older and larger Member States, in
correlation with the size of the respective pharmaceutical markets.
(27) The very large number of settlements in Portugal is likely explained by the
implementation of Portuguese Law 62/2011 published on 12 December 2011.12
In that regard, of the 100 settlements covering Portugal, 58% (58) were related
to this new legislation and covered only that Member State. Nevertheless, it
must be stated that it is unknown how many of these settlements would also
have been concluded absent the new law.
12
This law essentially provides that an originator must initiate arbitration proceedings within 30 days of
the publication of a marketing authorisation application by a generic company. If they do not comply
with this provision, the originators then lose the ability to assert their IP rights. Hence, originators in
Portugal are, since 2012, obliged to systematically bring arbitration proceedings against all generics
applying for marketing authorisations. Many of these proceedings, where there is no issue on the
validity of the underlying rights, are settled immediately with the generic agreeing to entry only after
patent expiry.
10
3.2. Categories of patent settlements
(28) The subsequent section describes in more detail the different types of patent
settlement agreements concluded between generic and originator companies in
the period concerned by this monitoring exercise.
(29) The percentage of settlements according to the categories outlined above in
section 2 is shown below in Figure 4.
(30) Thus 43% (78 of 183) of settlements did not limit generic market entry at all
(category A), whereas 51% (93) limited generic market entry but did not show a
value transfer from originator to generic company (category B.I) and only 7%
(12) limited generic market entry showing a value transfer from the originator
to the generic company. If one puts aside the settlements related to the new law
in Portugal mentioned above, category B.I amounts to 30% (37 of 125) of all
settlements, category A to 61% (76) and category B.II to 10% (12). This
compares as follows to numbers of settlements according to categories in
previous years:
11
2000 –
2008 (1st
half)
2008 (2nd
half) - 2009
2010 2011
2012
All Excluding
PT-related
Category A
52%
57%
61%
70% 43% 61%
Category B.I
26%
33%
36%
19% 51% 30%
Category B.II
22%
10%
3%
11% 7% 10%
Source: European Commission, Pharmaceutical Sector Inquiry and first four Patent Settlement
Monitoring Exercises. Note: new legislation was adopted in Portugal in 2012, which practically mandates arbitration
proceedings between originators and marketing authorisation applicants. When the IPRs are not
contested by the generic company, the proceedings are immediately settled. Hence, figures are
provided which disregard settlements related to the new law in Portugal. It must, however, also be
noted that it is not known how many of these settlements would have still taken place absent the
new law.
Note: percentages may not add-up to exactly 100% due to the rounding-up of figures.
Category A Settlements: Settlements that do not limit generic entry
(31) As presented in Figure 4 above, 43% of all patent settlements (78 of 183) did
not limit the generic company's entry into the market (category A). The generic
company was thus free to market its own generic product in the geographic
market concerned, under the conditions chosen by the generic company itself.
(32) Litigating parties may enter into category A settlement agreements for a variety
of reasons. The terms of the settlement agreements took various forms,
depending amongst others on whether or not the generic company had entered
the market (at risk) or whether the settlement was concluded close to the time
when the originator company lost exclusivity anyhow.
(33) Figure 5 below distinguishes between different category A settlements
according to the value transfer connected to them, if any.
12
(34) From this figure it becomes clear that 44% of the category A settlement
agreements (34 of 78) did not include any payment or value transfer, but were
concluded on a so-called "walk-away" basis, i.e. settlements where both parties
agreed to simply discontinue their litigation without any further
commitment/obligation on any of them. Such an agreement would appear to be
the most likely outcome if both parties believe that continuing the litigation
would be a waste of time and/or resources.
(35) In addition, it appears that, while in 67% (52 out of 78) of category A
settlements the relevant patent(s) was not in force anymore at the time of
signature, in the other 33% of cases (26 out of 78) the relevant patent(s) was
still in force.
(36) A value transfer from the originator company to the generic company took
place in 47% of the category A settlements (37 of 78). In most cases these were
payments covering litigation costs and/or damages. The latter happened, for
example, when an originator company had originally obtained an interim
injunction against a generic company's product, but later feared to lose the main
case. Under such circumstances, the generic company could claim damages for
the lost sales it incurred whilst it was prevented from marketing its product.
(37) In 9% (7) of the cases a value transfer from the generic company to the
originator company took place. An example of such a settlement could be that
the generic company had entered the market at risk. However, during the course
of litigation the patents concerned expired, which would leave the generic
company free to enter the market. Nonetheless, in these cases the litigation
13
could have continued e.g. if the originator wanted to assert the infringement
committed by the generic company up until the time the patent expired in order
to recover damages from the generic for such an infringement. Faced with a
high probability that the courts would find such an infringement if the case were
to proceed, the generic company decided to settle by paying compensation to
the originator company, covering legal fees and possibly an additional amount
in damages in order to avoid further litigation.
(38) For the sake of completeness it is worth pointing out that in some cases an
originator had granted a royalty free license to the generic to enter with its own
product. As mentioned above, this was not counted as a restriction, as the
generic company was free to enter the market without any restrictions e.g. as to
the composition, quantities, pricing or other marketing conditions of the
product.
(39) The table below offers a comparison to the numbers of previous monitoring
exercises and the sector inquiry:
2000 – 2008
(1st half)
2008 (2nd
half) -2009
2010 2011 2012
All Excluding
PT-related
Category A with
value transfer
from originator
company
14%
25%
13%
18% 47% 49%
Category A with
value transfer
from generic
company
17%
7%
11%
9% 9% 9%
Category A
without value
transfer
69%
68%
76%
71% 44% 42%
Category A with
value transfer in
both directions
-
-
-
2% - -
Source: European Commission, Pharmaceutical Sector Inquiry and first four Patent Settlement
Monitoring Exercises. Note: new legislation was adopted in Portugal in 2012, which practically mandates arbitration
proceedings between originators and marketing authorisation applicants. When the IPRs are not
contested by the generic company, the proceedings are immediately settled. Hence, figures are
provided which disregard settlements related to the new law in Portugal. It must, however, also be
noted that it is not known how many of these settlements would have still taken place absent the new
law.
14
Category B Settlements: Settlements that limit generic entry
(40) As already explained in section 2, settlements that limit generic entry can be
divided into two subcategories, namely those that do not include a value
transfer from the originator to the generic company (category B.I) and those
that do (category B.II). Both of them will be looked at in turn.
Category B I Settlements: Settlements limiting generic entry without value
transfer from originator to generic company
(41) In the period investigated, B.I agreements accounted for 51% (93 of 183) of all
agreements (see table in paragraph (30)). Within the category B agreements,
they accounted for 89% (93 of 105). The common features of the B.I
settlements as analysed in this section are that they restricted generic entry but
did not contain a value transfer from the originator to the generic company. Yet,
some of those settlements showed a value transfer from the generic to the
originator company. Thus, Figure 6 breaks down the number of B.I settlements
into those that contained a value transfer from the generic to the originator
company and those that did not.
(42) In these agreements the generic company agreed to enter only after the patent(s)
at issue had expired. The main characteristic of this category seems to be that
the generic accepted the validity of the originator's patent. In 2% (2) of these
instances, the generic company also agreed to compensate the originator
company for its legal costs (see Figure 6 below). The other 98% (91) of cases
showed no value transfer from the generic company.
15
(43) It must be noted that 60% (56 out of 93) of B.I. settlements were signed in the
context of the new legislation in Portugal, as explained above (see paragraphs
(27) and (50)).
(44) Again the table below offers a comparison to the numbers of previous
monitoring exercises13
:
2008 (2
nd
half) - 2009
2010 2011 2012
(all
settlements)
2012
(excluding
PT-
related)
Category B.I
with value
transfer from
generic to
originator
company
29% 16% 17% 2% 5%
Category B.I
without value
transfer from
generic
company
71% 84% 83% 98% 95%
Source: European Commission, First four Patent Settlement Monitoring Exercises. Note: new legislation was adopted in Portugal in 2012, which practically mandates arbitration
proceedings between originators and marketing authorisation applicants. When the IPRs are not
contested by the generic company, the proceedings are immediately settled. Hence, figures are
provided which disregard settlements related to the new law in Portugal. It must, however, also be
noted that it is not known how many of these settlements would have still taken place absent the new
law.
13
Note that this evaluation was not carried out during the sector inquiry.
16
Category B II Settlements: Settlements limiting generic entry with value
transfer from originator to generic company
(45) In the period investigated, B.II agreements accounted for 7% (12 of 183) of all
agreements (see table in paragraph (30)). Within the category B agreements,
they accounted for 11% (12 of 105). Figure 7 divides them according to the
type of value transfer.
(46) The value transfer flowing to generic companies in the settlement agreements
took four forms, sometimes in various combinations: early entry14
, a licence, a
supply agreement and the buying of old stock. 17% (2 of 12) of B.II agreements
only enabled entry at the time the patent lapsed and included a payment and a
licence to the generic company. 42% (5 of 12) enabled early entry without a
licence or a distribution agreement. 33% (4 of 12) combined early entry with a
license to the generic company, and 8% (1 of 12) combined it with a license and
14
A non-assert clause, whereby - even without a license - the originator binds itself not to invoke the
patent against the generic company, thereby allowing the generic medicine to come onto the market,
may technically be perceived as constituting a value transfer. However, an agreement which includes
no other limitative provision than determining the date of the generic entry with the originator's
undertaking not to challenge such entry (a "pure early entry") is not likely to attract the highest degree
of antitrust scrutiny.
17
supply agreement. Companies claimed that there were no stand-alone direct
cash payments from originator to generic company15
.
(47) It should be noted that this report merely summarises the results of the
monitoring exercise and no decision has been taken or implied on further
investigation of any of the settlement agreements reported under this or any
other category. As mentioned above, if examined, an assessment of the
particular facts of each individual case would have to be undertaken, e.g.
whether a license granted to the generic company may in fact have pro-
competitive effects, depending on the restrictions and conditions within that
license16
.
15
Companies claimed that payments were compensation for legal costs or damages, or the purchase of
old stock.
16 Hence, such investigations will also consider arguments raised by parties pointing to any potential pro-
competitive effects of the settlements.
18
4. Conclusion
(48) The fourth monitoring exercise undertaken by the Commission covered the
period of 1 January 2012 until 31 December 2012, i.e. 12 months. It unearthed
183 patent settlement agreements concluded in the EEA. In line with the
upward trend described in the previous monitoring reports covering the period 1
July 2008 to 31 December 2009, 1 January 2010 to 31 December 2010 and 1
January 2011 to 31 December 2011, the present exercise has confirmed the
increasing use of patent settlements in the European pharmaceutical sector
measured by the number of patent settlements concluded. The specific situation
of Portugal must nevertheless be kept in mind, in the absence of which the
number of settlements still shows a slight increase17
. The annual average of 24
patent settlements concluded in the period covered by the sector inquiry (from 1
January 2000 to 30 June 2008 - in total 207 settlements in eight and a half
years) steadily increased to 183 settlements in the year 2012.18
Also, the
number of INNs which were the subject of settlements increased significantly
from less than 10 INNs in the first three years of the millennium to more than
40 in 2012. As with the former three exercises, the results of the fourth
monitoring exercise show that the Commission's announcement that it would
continue scrutinizing B.II category settlements in the future has not hindered
companies from concluding settlements in general.
(49) The number of B.II settlements, i.e. settlements which restrict generic entry and
show a value transfer from the originator to the generic company and which
might attract competition law scrutiny, have stabilized at a low level. In the
period covered by the sector inquiry (1 January 2000 to 30 June 2008), B.II
settlements represented 22% of all settlements reported, or five settlements per
year on average. This percentage has decreased steadily over the years to reach
7% in the period of this exercise or 12 in absolute terms, after reaching 11% (13
in absolute terms) in 2011. Note that even omitting agreements related to the
new law in Portugal, this figure would still stabilise at just 10%.
(50) The trend concerning B.I settlements shows first a steady increase from 26% or
six settlements on average per year (from 1 January 2000 to 30 June 2008) to
33% or 21 settlements per year (from 1 July 2008 to 31 December 2009) and
36% or 32 settlements in 2010. However, such settlements showed a decrease
in 2011 to 19% or 23 settlements in absolute terms. In 2012, they increased to
account for 51% or 93 settlements in absolute terms. Nevertheless, if
settlements related to the new law in Portugal are put aside, B.I settlements then
account for 30% or 37 settlements in absolute terms in 2012, figures similar to
those of the first two monitoring exercises.
17
If one omits the 58 settlements related to the new law in Portugal, the number of settlements for 2012
is 125.
18 With an average of 62 settlements per year in the period of the first monitoring exercise (mid 2008 -
end 2009) and 89 settlements in the period of the second monitoring exercise (covering the year
2010).
19
(51) The statements of certain stakeholders during the sector inquiry that the
Commission would be forcing companies to litigate each patent dispute until
the end has proved to be unfounded, given the substantial increase in
settlements overall (183 in 2012 compared to 24 per year in the period of 1
January 2000 to 30 June 2008). In addition, 93% of the settlements fall into
categories that prima facie raise no need for competition law scrutiny.
Companies, in most cases, are able to solve their disputes in a manner that is
typically considered unproblematic from a competition law perspective.
(52) In the future the Commission may decide to continue the monitoring exercise in
order to examine further the development of the foregoing trends.